Music and ABS as a Potential Anxiety Intervention

NCT05442086 | Completed

• 1 other identifier: 2020-068 LUCiD Anxiety
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Anxiety is a growing problem and has been steadily increasing, particularly in the adolescent and young adult populations in the past 24 years. Music and auditory beat stimulation (ABS) in the theta frequency range (4-7 Hz) are sound-based anxiety treatments that have been investigated in prior studies with subjective measures of anxiety. Here, the anxiety-reducing potential of calm music combined with theta ABS will be examined in a large sample of participants with objective psychophysiological measures (heart rate variability and EEG), stress hormone measures (salivary cortisol) along with subjective measures (STICSA state). Participants with a GAD-2 score of 1 or higher (indicating generalized anxiety) will be randomly assigned to a single 24-27 minute session of sound-based treatment: combined (music \& ABS), or pink noise (control). Pre- and post-intervention heart rate variability and EEG band power (alpha, beta, delta, and theta bands), salivary cortisol, along with somatic and cognitive state anxiety measures (STICSA State) will be collected along with trait anxiety (STICSA Trait), and music absorption (Absorption in Music Scale). The investigators predict that the music \& ABS condition will have significantly increased power in the theta and alpha bands, higher heart rate variability, higher state anxiety reduction, and lower salivary cortisol levels compared to the pink noise control condition.

Conditions

Anxiety State

Outcome Measures

Primary Outcomes (5)

• Anxiety: EEG band power (alpha, beta, delta and theta bands)

  EEG band power is a good objective physiological measure of anxiety and relaxation. It has good reliability and validity and has been used as an anxiety/relaxation measure in multiple studies (Aftanas, Pavlov, Reva, \& Varlamov, 2003; Gálvez, Recuero, Canuet, \& Del-Pozo, 2018; Knyazev, Savostyanov, \& Levin, 2005; Lee, Bhattacharya, Sohn, \& Verres, 2012; Tarrant, Viczko, \& Cope, 2018).

  24-27 minutes

• Anxiety: Heart rate variability (HRV)

  Heart rate variability is a good objective physiological measure of anxiety. It has good reliability and validity and has been used as an anxiety measure in multiple studies (Chalmers, Quintana, Abbott, \& Kemp, 2014; Gorman \& Sloan, 2000; Licht, de Geus, van Dyck, \& Penninx, 2009; Pittig, Arch, Lam, \& Craske, 2013).

  24-27 minutes

• Anxiety: Stress hormone levels: Salivary cortisol

  Salivary cortisol is a good objective measure of stress and anxiety. It has good reliability and validity and has been used as an anxiety measure in multiple studies (Mantella et al., 2008; Vedhara et al., 2003; Vreeburg et al., 2010).

  24-27 minutes

• Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)

  The State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) is a 21-item measure designed to measure somatic (11 items) and cognitive symptoms (10 items) of anxiety at both the trait and state levels. To differentiate between state and trait anxiety symptoms, participants will complete two versions of the measure, one where they rate how they "feel right now at this very moment" (STICSA-State) and one where they rate "how they feel in general" (STICSA-Trait). Respondents rate the degree to which each item is true for them on a Likert scale ranging from 1 = not at all to 4 = very much so. Scores on the STICSA can range from 10 - 40 (cognitive) or 11 - 44 (somatic), with higher scores indicating greater anxiety.

  24-27 minutes

• Self-Assessment Manikin

  Two series of Self-Assessment Manikins (SAM) will be administered to assess state emotional valence and arousal before and after the audio intervention. Participants will be asked to rate on two scales with accompanying images how they are feeling right now (unhappy to happy) and their energy levels from calm to excited both on a scale from 1-5. The pre-intervention SAM serves two purposes: the first, to assess baseline affect and the second, to select the playlist that the participant listens to if assigned to the audio intervention. The post-intervention SAM will serve to assess changes in affect following the intervention.

  24-27 minutes

Secondary Outcomes (3)

• Mood: Positive and Negative Affect Scale (PANAS)

  24-27 minutes

• Absorption in Music Scale (AIMS)

  24-27 minutes

• Anxiety Coping Measures

  24-27 minutes

Study Arms (2)

Music and Theta Auditory Beat Stimulation

EXPERIMENTAL

Behavioural: Listening to calm music and auditory beat stimulation Participants will listen to calm music with theta auditory beat stimulation for 24-27 minutes

Behavioral: Music and Theta Auditory Beat Stimulation

Pink Noise (control)

SHAM COMPARATOR

Behavioural: Listening to pink noise Participants will listen to pink noise for 24 minutes

Behavioral: Pink Noise (control)

Interventions

Music and Theta Auditory Beat Stimulation BEHAVIORAL

Participants will listen to calm music with theta auditory beat stimulation for 24-27 minutes

Music and Theta Auditory Beat Stimulation

Pink Noise (control) BEHAVIORAL

Participants will listen to pink noise for 24 minutes

Pink Noise (control)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• GAD-2 score of 1 or higher indicating generalized anxiety.
• Age between 18-30 years
• Undergraduate student
• Comfortable speaking and understanding English
• Self-reported normal hearing

You may not qualify if:

• Self-reported history of cardiovascular conditions (e.g., arrhythmia, heart disease)
• History of seizures or epilepsy

Sponsors & Collaborators

• Toronto Metropolitan University: lead

Study Sites (1)

Toronto Metropolitan University

Toronto, Ontario, M5B 2K3, Canada

Location

Related Publications (29)

• Aftanas LI, Pavlov SV, Reva NV, Varlamov AA. Trait anxiety impact on the EEG theta band power changes during appraisal of threatening and pleasant visual stimuli. Int J Psychophysiol. 2003 Nov;50(3):205-12. doi: 10.1016/s0167-8760(03)00156-9.

  PMID: 14585489 BACKGROUND

• Bados A, Gomez-Benito J, Balaguer G. The state-trait anxiety inventory, trait version: does it really measure anxiety? J Pers Assess. 2010 Nov;92(6):560-7. doi: 10.1080/00223891.2010.513295.

  PMID: 20954057 BACKGROUND

• Bringman H, Giesecke K, Thorne A, Bringman S. Relaxing music as pre-medication before surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2009 Jul;53(6):759-64. doi: 10.1111/j.1399-6576.2009.01969.x. Epub 2009 Apr 14.

  PMID: 19388893 BACKGROUND

• Chalmers JA, Quintana DS, Abbott MJ, Kemp AH. Anxiety Disorders are Associated with Reduced Heart Rate Variability: A Meta-Analysis. Front Psychiatry. 2014 Jul 11;5:80. doi: 10.3389/fpsyt.2014.00080. eCollection 2014.

  PMID: 25071612 BACKGROUND

• Davis, W. B., & Thaut, M. H. (1989). The Influence of Preferred Relaxing Music on Measures of State Anxiety, Relaxation, and Physiological Responses. Journal of Music Therapy, 26(4), 168-187. doi:10.1093/jmt/26.4.168

  BACKGROUND

• Galvez G, Recuero M, Canuet L, Del-Pozo F. Short-Term Effects of Binaural Beats on EEG Power, Functional Connectivity, Cognition, Gait and Anxiety in Parkinson's Disease. Int J Neural Syst. 2018 Jun;28(5):1750055. doi: 10.1142/S0129065717500551. Epub 2017 Nov 13.

  PMID: 29297265 BACKGROUND

• Gorman JM, Sloan RP. Heart rate variability in depressive and anxiety disorders. Am Heart J. 2000 Oct;140(4 Suppl):77-83. doi: 10.1067/mhj.2000.109981.

  PMID: 11011352 BACKGROUND

• Gray, E. K., Watson, D. (2007). Assessing positive and negative affect via self-report. In J. A. Coan, Allen, J.J.B. (Ed.), Handbook of emotion elicitation and assessment. New York, NY: Oxford University Press.

  BACKGROUND

• Gros DF, Antony MM, Simms LJ, McCabe RE. Psychometric properties of the State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA): comparison to the State-Trait Anxiety Inventory (STAI). Psychol Assess. 2007 Dec;19(4):369-81. doi: 10.1037/1040-3590.19.4.369.

  PMID: 18085930 BACKGROUND

• Isik BK, Esen A, Buyukerkmen B, Kilinc A, Menziletoglu D. Effectiveness of binaural beats in reducing preoperative dental anxiety. Br J Oral Maxillofac Surg. 2017 Jul;55(6):571-574. doi: 10.1016/j.bjoms.2017.02.014. Epub 2017 Mar 18.

  PMID: 28325532 BACKGROUND

• Jongkees BJ, Colzato LS. Spontaneous eye blink rate as predictor of dopamine-related cognitive function-A review. Neurosci Biobehav Rev. 2016 Dec;71:58-82. doi: 10.1016/j.neubiorev.2016.08.020. Epub 2016 Aug 21.

  PMID: 27555290 BACKGROUND

• Knyazev GG, Savostyanov AN, Levin EA. Uncertainty, anxiety, and brain oscillations. Neurosci Lett. 2005 Oct 28;387(3):121-5. doi: 10.1016/j.neulet.2005.06.016.

  PMID: 16002215 BACKGROUND

• Lagopoulos J, Xu J, Rasmussen I, Vik A, Malhi GS, Eliassen CF, Arntsen IE, Saether JG, Hollup S, Holen A, Davanger S, Ellingsen O. Increased theta and alpha EEG activity during nondirective meditation. J Altern Complement Med. 2009 Nov;15(11):1187-92. doi: 10.1089/acm.2009.0113.

  PMID: 19922249 BACKGROUND

• Lee EJ, Bhattacharya J, Sohn C, Verres R. Monochord sounds and progressive muscle relaxation reduce anxiety and improve relaxation during chemotherapy: a pilot EEG study. Complement Ther Med. 2012 Dec;20(6):409-16. doi: 10.1016/j.ctim.2012.07.002. Epub 2012 Aug 23.

  PMID: 23131371 BACKGROUND

• Licht CM, de Geus EJ, van Dyck R, Penninx BW. Association between anxiety disorders and heart rate variability in The Netherlands Study of Depression and Anxiety (NESDA). Psychosom Med. 2009 Jun;71(5):508-18. doi: 10.1097/PSY.0b013e3181a292a6. Epub 2009 May 4.

  PMID: 19414616 BACKGROUND

• Luque-Casado A, Perakakis P, Ciria LF, Sanabria D. Transient autonomic responses during sustained attention in high and low fit young adults. Sci Rep. 2016 Jun 8;6:27556. doi: 10.1038/srep27556.

  PMID: 27271980 BACKGROUND

• Mantella RC, Butters MA, Amico JA, Mazumdar S, Rollman BL, Begley AE, Reynolds CF, Lenze EJ. Salivary cortisol is associated with diagnosis and severity of late-life generalized anxiety disorder. Psychoneuroendocrinology. 2008 Jul;33(6):773-81. doi: 10.1016/j.psyneuen.2008.03.002. Epub 2008 Apr 14.

  PMID: 18407426 BACKGROUND

• McConnell PA, Froeliger B, Garland EL, Ives JC, Sforzo GA. Auditory driving of the autonomic nervous system: Listening to theta-frequency binaural beats post-exercise increases parasympathetic activation and sympathetic withdrawal. Front Psychol. 2014 Nov 14;5:1248. doi: 10.3389/fpsyg.2014.01248. eCollection 2014.

  PMID: 25452734 BACKGROUND

• Padmanabhan R, Hildreth AJ, Laws D. A prospective, randomised, controlled study examining binaural beat audio and pre-operative anxiety in patients undergoing general anaesthesia for day case surgery. Anaesthesia. 2005 Sep;60(9):874-7. doi: 10.1111/j.1365-2044.2005.04287.x.

  PMID: 16115248 BACKGROUND

• Pittig A, Arch JJ, Lam CW, Craske MG. Heart rate and heart rate variability in panic, social anxiety, obsessive-compulsive, and generalized anxiety disorders at baseline and in response to relaxation and hyperventilation. Int J Psychophysiol. 2013 Jan;87(1):19-27. doi: 10.1016/j.ijpsycho.2012.10.012. Epub 2012 Oct 27.

  PMID: 23107994 BACKGROUND

• Reedijk SA, Bolders A, Hommel B. The impact of binaural beats on creativity. Front Hum Neurosci. 2013 Nov 14;7:786. doi: 10.3389/fnhum.2013.00786. eCollection 2013.

  PMID: 24294202 BACKGROUND

• Reedijk SA, Bolders A, Colzato LS, Hommel B. Eliminating the Attentional Blink through Binaural Beats: A Case for Tailored Cognitive Enhancement. Front Psychiatry. 2015 Jun 4;6:82. doi: 10.3389/fpsyt.2015.00082. eCollection 2015.

  PMID: 26089802 BACKGROUND

• Roberts KE, Hart TA, Eastwood JD. Factor structure and validity of the State-Trait Inventory for Cognitive and Somatic Anxiety. Psychol Assess. 2016 Feb;28(2):134-146. doi: 10.1037/pas0000155. Epub 2015 May 25.

  PMID: 26011481 BACKGROUND

• Tarrant J, Viczko J, Cope H. Virtual Reality for Anxiety Reduction Demonstrated by Quantitative EEG: A Pilot Study. Front Psychol. 2018 Jul 24;9:1280. doi: 10.3389/fpsyg.2018.01280. eCollection 2018.

  PMID: 30087642 BACKGROUND

• Vedhara K, Miles J, Bennett P, Plummer S, Tallon D, Brooks E, Gale L, Munnoch K, Schreiber-Kounine C, Fowler C, Lightman S, Sammon A, Rayter Z, Farndon J. An investigation into the relationship between salivary cortisol, stress, anxiety and depression. Biol Psychol. 2003 Feb;62(2):89-96. doi: 10.1016/s0301-0511(02)00128-x.

  PMID: 12581685 BACKGROUND

• Vreeburg SA, Zitman FG, van Pelt J, Derijk RH, Verhagen JC, van Dyck R, Hoogendijk WJ, Smit JH, Penninx BW. Salivary cortisol levels in persons with and without different anxiety disorders. Psychosom Med. 2010 May;72(4):340-7. doi: 10.1097/PSY.0b013e3181d2f0c8. Epub 2010 Feb 26.

  PMID: 20190128 BACKGROUND

• Wahbeh H, Calabrese C, Zwickey H. Binaural beat technology in humans: a pilot study to assess psychologic and physiologic effects. J Altern Complement Med. 2007 Jan-Feb;13(1):25-32. doi: 10.1089/acm.2006.6196.

  PMID: 17309374 BACKGROUND

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• Ueberholz R, Glassman H, Mallik A, Russo FA. Effectiveness of music with auditory beat stimulation in reducing state anxiety in Canadian students with trait anxiety: protocol for a randomised controlled trial. BMJ Open. 2025 Jun 17;15(6):e094784. doi: 10.1136/bmjopen-2024-094784.

  PMID: 40527557 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Frank Russo, PhD

  Toronto Metropolitan University (formerly Ryerson University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: August 10, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available on the Open Science Framework (osf.io) when the pre-print of the study is uploaded to PsyArXiv. After that point the data will be available for a period of 5 years.
• Access Criteria: All supporting information will be publicly accessible on the Open Science Framework (osf.io).

Locations

CA (1)